Trial Title:
Gemcitabine, Cisplatin and Nab-Paclitaxel As Neoadjuvant Treatment for Patients with Resectable or Borderline Resectable Pancreatic Cancer
NCT ID:
NCT06423326
Condition:
Borderline Resectable Pancreatic Ductal Adenocarcinoma
Resectable Pancreatic Adenocarcinoma
Stage I Pancreatic Cancer AJCC V8
Stage II Pancreatic Cancer AJCC V8
Stage III Pancreatic Cancer AJCC V8
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Given IV
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
Abiplatin
Other name:
Blastolem
Other name:
Briplatin
Other name:
CDDP
Other name:
Cis-diammine-dichloroplatinum
Other name:
Cis-diamminedichloridoplatinum
Other name:
Cis-diamminedichloro Platinum (II)
Other name:
Cis-diamminedichloroplatinum
Other name:
Cis-dichloroammine Platinum (II)
Other name:
Cis-platinous Diamine Dichloride
Other name:
Cis-platinum
Other name:
Cis-platinum II
Other name:
Cis-platinum II Diamine Dichloride
Other name:
Cismaplat
Other name:
Cisplatina
Other name:
Cisplatinum
Other name:
Cisplatyl
Other name:
Citoplatino
Other name:
Citosin
Other name:
Cysplatyna
Other name:
DDP
Other name:
Lederplatin
Other name:
Metaplatin
Other name:
Neoplatin
Other name:
Peyrone's Chloride
Other name:
Peyrone's Salt
Other name:
Placis
Other name:
Plastistil
Other name:
Platamine
Other name:
Platiblastin
Other name:
Platiblastin-S
Other name:
Platinex
Other name:
Platinol
Other name:
Platinol- AQ
Other name:
Platinol-AQ
Other name:
Platinol-AQ VHA Plus
Other name:
Platinoxan
Other name:
Platinum
Other name:
Platinum Diamminodichloride
Other name:
Platiran
Other name:
Platistin
Other name:
Platosin
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Given IV
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
dFdC
Other name:
dFdCyd
Other name:
Difluorodeoxycytidine
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Given IV
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
ABI 007
Other name:
ABI-007
Other name:
Abraxane
Other name:
Albumin-bound Paclitaxel
Other name:
Albumin-Stabilized Nanoparticle Paclitaxel
Other name:
Nanoparticle Albumin-bound Paclitaxel
Other name:
Nanoparticle Paclitaxel
Other name:
Paclitaxel Albumin
Other name:
paclitaxel albumin-stabilized nanoparticle formulation
Other name:
Paclitaxel Nanoparticle Albumin-bound
Other name:
Paclitaxel Protein-Bound
Other name:
Protein-bound Paclitaxel
Intervention type:
Procedure
Intervention name:
Pancreatic Surgical Procedure
Description:
Undergo surgical resection
Arm group label:
Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Other name:
Pancreatic Surgery
Summary:
This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before
surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be
removed by surgery (resectable) or that is borderline resectable. The standard treatment
for resectable and borderline resectable pancreatic cancer is a combination of surgery
and chemotherapy. Neoadjuvant therapy has been shown to improve overall survival compared
to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the
cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications
known as platinum-containing compounds. It works by killing, stopping or slowing the
growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation
of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing
and may kill them. Nab-paclitaxel may have fewer side effects and work better than other
forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective
neoadjuvant treatment option for patients with resectable or borderline resectable
pancreatic cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. Determine the major pathological response rate, feasibility and safety of biweekly
gemcitabine, cisplatin and nab-paclitaxel (GCN) in the neoadjuvant setting for patients
with resectable and borderline resectable pancreatic ductal adenocarcinoma.
SECONDARY OBJECTIVE:
I. Determine if neoadjuvant GCN increases tumoral infiltration of lymphocytes with local
and systemic phenotypic features that assist in the antitumor immune response.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes, cisplatin IV over 60
minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment
repeats every 28 days for up to 4 cycles in the absence of disease progression or
unacceptable toxicity. Patients with stable disease, partial or complete response undergo
surgical resection per standard of care. Additionally, patients undergo biopsy on study
and undergo blood sample collection and computed tomography (CT) or magnetic resonance
imaging (MRI) at pre-study and on study.
After completion of study treatment, patients are followed up every 3-4 months for up to
24 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed - resectable and borderline resectable
pancreatic ductal adenocarcinoma
- Resectability will be defined as per National Comprehensive Cancer Network
(NCCN) guidelines using cross-sectional imaging (contrast-enhanced computed
tomography or magnetic resonance imaging scans of the abdomen, and pelvis)
- Decisions about resectability status will be made in consensus at
multidisciplinary meetings/discussions
Resectable disease will be defined as:
- No interface of the tumor with celiac artery, common hepatic artery (CHA), or
superior mesenteric arteries (SMA) (and, if present, variants)
- Less than 180° interface between tumor and vessel wall of the portal or superior
mesenteric veins (SMV) without vein contour irregularity
- For tumors of the body and tail of the pancreas, interface with the splenic artery
and splenic vein of any degree will be considered resectable disease
Borderline resectable disease will be defined as:
- To include at least one of the following:
- Tumor abutment < 180° of the superior mesenteric artery or celiac axis
- Solid tumor contact with CHA without extension to celiac artery (CA) or hepatic
artery bifurcation allowing for safe and complete resection and reconstruction
- Solid tumor contact with variant arterial anatomy (ex: accessory right hepatic
artery, replaced right hepatic artery, replaced CHA, and the origin of replaced
or accessory artery)
- Tumor induced narrowing of SMV, portal vein (PV) or SMV-PV of > 180˚ of the
diameter of the vessel
- Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and
SMV below, for reconstruction
- Solid tumor contact with inferior vena cava
- Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral
biopsy or endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA)
- No distant extrapancreatic disease (M0)
- Adults > 18 years of age
- Able to give informed consent
- Able to adhere to study visit schedule and other protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Absolute neutrophil count (ANC) ≥ 1,500 cells/ul
- Platelet count ≥ 100,000 cells/ul
- Hemoglobin ≥ 9 g/dL
- Serum total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5
x ULN
- Albumin ≥ 3 g/dl
- Creatinine ≤ 1.5 x ULN
- Male, or a non-pregnant and non-lactating female
- Women of child-bearing potential - defined as a sexually mature woman who
has not undergone hysterectomy - the surgical removal of the uterus or
bilateral oophorectomy - the surgical removal of both ovaries or has not
been naturally postmenopausal for at least 24 consecutive months, i.e.,
has had menses at any time during the preceding 24 consecutive months,
must commit to true abstinence from heterosexual contact, or agree to use,
and be able to comply with, effective contraception without interruption
for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel
(including dose interruptions) until treatment with
gemcitabine/cisplatin/nab-paclitaxel is complete
- Male subjects must practice true abstinence or agree to use a condom
during sexual contact with a female of childbearing potential or a
pregnant female while on treatment (including during dose interruptions)
with gemcitabine/cisplatin/nab-paclitaxel and for 6 months following
gemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has
undergone a successful vasectomy
Exclusion Criteria:
- Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for
Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is
defined as "moderate symptoms; limiting instrumental activities of daily living
(ADLs)"
- Concurrent severe and/or uncontrolled medical conditions which could compromise
participation in the study such as unstable angina, myocardial infarction within 6
months, unstable symptomatic arrhythmia, symptomatic congestive heart failure,
uncontrolled diabetes, serious active, uncontrolled infection after inadequate
biliary drainage if tumor obstructing bile duct, or psychiatric illness/social
situations
- Pregnancy (positive pregnancy test) or lactation
- Known central nervous system (CNS) disease, except for treated brain metastasis.
Treated brain metastases are defined as having no evidence of progression or
hemorrhage after treatment and no ongoing requirement for dexamethasone, as
ascertained by clinical examination and brain imaging (MRI or CT) during the
screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain
metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery
[RS]; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as
deemed appropriate by the treating physician. Patients with CNS metastases treated
by neurosurgical resection or brain biopsy performed within 3 months prior to day 1
will be excluded
- Previous (within the past 5 years) or concurrent presence of other untreated cancer,
except nonmelanoma skin cancer and in situ carcinomas
- History of allergy or hypersensitivity to any of the study drugs
- Current abuse of alcohol or illicit drugs
- Inability or unwillingness to sign the informed consent form
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kathleen M. Coleman
Email:
kathleen.marie.coleman@emory.edu
Contact backup:
Last name:
Mihir M. Shah, MD
Start date:
August 6, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06423326
